gke Steri-Record® Orange PCD

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Orange PCD
“A process challenge device that can do everything?”

This article is sponsored content brought to you by gke Australia.

Why can the Orange PCD be used as a Bowie Dick Test and a Helix test?

The Australian Standard for Office Based Practice (AS/NZS 4815:2006) is derived from International Standards. EN 13060:2004 and EN 867-5:2001 are the International Standards for Small Steam Sterilisers.

EN 867-5 defines the specifications for the test to be used in daily start-up testing of small steam sterilisers. This test is known as a “Daily Air Removal and Steam Penetration Test” in AS/NZS 4815:2006.

A Bowie Dick Test was the first test of its kind for start-up testing of porous loads in large steam sterilisers back in 1963, however this sort of test only makes sense nowadays for porous type loads in large steam sterilisers. As such “Bowie Dick Tests” are only defined in EN 285, which is the International Standard for large steam sterilisers.

The terminology – Bowie Dick Test | Helix Test | Daily Air Removal and Steam Penetration Test – are all synonymous by definition. They are the mandatory first test we do in our steriliser at start-up in an empty chamber to make sure our steriliser is capable of air removal and steam penetration in our instruments we will be sterilising throughout the day. It is a functionality check of our steriliser.

Therefore in accordance with the requirements of EN 867-5 – a test meeting this standard is the only test we must conduct in our empty chamber at start-up.

How can the Orange PCD simulate complex hollow instruments, solid instruments and porous loads?

Complex hollow instruments, like hand pieces and burs, are more difficult to sterilise than solid instruments and porous items like gauze, because it is more difficult to remove the air that may be trapped inside the instrument, and subsequently more difficult to ensure steam has penetrated all internal surfaces. We can imagine it is easy to sterilise a solid instrument like a mirror as there are no internal surfaces. Similarly porous items are easy to remove the air from and distribute steam to. Therefore, as the gke Orange PCD meets the requirements of the Hollow Load Test defined in EN 867-5, it is also capable of monitoring the sterilisation of solid and porous items in our loads.

What is Routine Monitoring?

Routine monitoring of every load represents best practice for your facility and more importantly, your patients.

If miniscule amounts of air remain trapped within instruments, the air can block steam from getting inside the instruments. Meaning the instruments could be released without an internal Sterility Assurance Level (SAL). To overcome this possibility it is recommended that the gke PCD be used in every load, i.e. routine monitoring. 

Why should we monitor every load?

Our daily start-up test is only a functionality test of the steriliser and not a test for sterility. Additionally our chart print-out cannot tell us about what is happening inside our instruments, only that the critical parameters have been met for the process. Also, if the vacuum pump in our steriliser becomes faulty throughout the day, without the use of the PCD, this fault would go undetected until the next day’s start-up air removal and steam penetration test. Meaning any instruments used during that day would not have an internal SAL, meaning potential risk to the patient.

Easy Usage and Interpretation

The indicator strips can be evaluated easily. Errors in a process can be quickly identified with the 4 bar indicator graduated colour change. Pass/Fail sheets are also available to assist staff in recognising correct colour change. Indicators are self-adhesive and can be adhered to process notes for documentation and tracking. 

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